FDA recall D-0444-2017

Mylan LLC. · Class II · drug

Product

Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.

Reason for recall

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2016-12-20
Report date
2017-02-01
Termination date
2018-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Caguas, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0444-2017